Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol

Female Infertility Clinical Trial

— CANTAPOR  

Official title:

Prospective Randomized Phase IV Study Comparing the Effect of Adding Clomiphencitrate Versus Placebo to a High Dose Versus a Minimal Dose GnRH Antagonist Protocol on the Number of Oocytes Collected From Women That Are Poor Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577472
• Other study ID #: CANTAPOR_2012
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: November 14, 2017

Study information

• Verified date: December 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the oocyte yield of infertile women with suspected or known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional® starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT has been conducted to compare the reproductive outcome of patients with POR as defined by the ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an additional increment of endogenous GT thus increasing the oocytes yield after controlled ovarian stimulation due to higher endogenous gonadotropin secretion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Age: >18 years < 43 years

• BMI: = 18 = 32 kg/m2

• Poor responder as defined by ESHRE working group

Exclusion Criteria:

• Age < 18 und > 43 years

• Pregnancy

• Breast feeding

• Uterine conditions interfering with endometrial proliferation and embryo implantation (submucous fibroids or polyps)

• Women diagnosed with PCOS according to the Rotterdam criteria

• Hyperprolactinaemia - untreated

• Both ovaries not accessible transvaginally for oocyte pick up

• Ovarian cysts of unclear dignity

• Evidence of hydrosalpinx on ultrasound

• Clinically significant severe systemic disease that are incompatible with pregnancy

• Known or suspected hypersensitivity to the active substances (gonadotrophins, ganirelix, progesterone, clomiphencitrate)

• Untreated thyroid or adrenal disorders

• Bleeding disorders

• Cancer

• Severe renal or hepatic dysfunction

• Necessity to take medication that could influence ovarian stimulation

• History of OHSS in prior IVF cycle

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female
• Ovarian Insufficiency

Intervention

Drug:
• High Dose Clomiphencitrat
100mg of clomiphencitrate(Serophene®) are added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
• Low Dose Clomiphencitrat
100mg of clomiphencitrate(Serophene®) are added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
• High Dose Placebo
Placebo is added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
• Low dose Placebo
Placebo is added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of collected oocytes		1 year
Secondary	Implantation rate		1 year